An integrated launch plan was just the start for helping to transform a research organization into a commercial entity. A successful commercial launch of an FDA-approved specialty drug included project management support to a cross-functional client team and development of a dashboard tool to track each function’s progress.

As the food industry races to comply with the FDA Food Safety Modernization Act (FSMA), manufacturers are working to adopt more robust track and trace processes. A critical component to achieving compliance is the integration of automated data capture solutions throughout all stages of food production—from farm to table. This whitepaper examines technology considerations food manufacturers should weigh when implementing these systems, along with how to tackle the subsequent challenges that are sure to arise. Once the U.S. food industry understands how mobile solutions can enable track & traceability, manufacturers will be equipped with an efficient solution that not only helps to achieve regulatory compliance, but also improves overall business efficiencies.

Cost reduction is a key criteria that executives often use when choosing initiatives to focus on. They are the ones that have the greatest potential to impact an organization's bottom line. Across life science organizations, a critical area for cost containment is training management.

This paper summarizes the results of a quantitative benchmarking survey to over 200 Life Science organizations. The study identifies the key compliance and performance improvement training topics they had addressed in 2011 along with key issues for 2012.

SOPs are critical to efficient manufacturing operations, quality control, and regulatory compliance. This paper reviews best practices for the Life Science industry for training on SOPs, and how learning management technology has the potential to improve learner retention through automated assessments.

Third party intermediaries have played starring roles in some of the most highly publicized global corruption trials. By any measure, third party intermediaries routinely rank high on the list of compliance worries for brand companies.

Good Manufacturing Practices (GMP) violations have become the new healthcare fraud as the Department of Justice (DOJ) tests out new legal theories under the False Claims Act (FCA). The Food and Drug Administration (FDA) has dusted off its regulatory authority to prosecute GMP violations.

Are you feeling the pressure to meet FDA guidelines on Quality by Design (QbD) principals for Process Validation?
Existing manufacturing, LIMS, ERP and document management tools are lacking integration and on demand view of your processes. They have hidden costs, risks and create delays to scalable product manufacturing and revenue.
Since the FDA is demanding scientific arguments to support process and product development activies and a lifecyle approach, consider the value of a purpose built app for Process Validation.
This new class of APP will bring your products to market faster and lower the risk of costly delays.
Download the Primer to learn more.

But what seems like a spoon full of sugar is often a tough pill to swallow when you consider regulatory requirements from agencies like the FDA for use of these networks. Adopting new technologies that allow employees to share information and exchange ideas with each other and with your customers is often the best way to achieve better business results, but doing so can involve considerable risk. That’s because the content people create using these technologies is subject to the scrutiny of regulators, legislators, and litigators. On top of that, increasing litigation has made it a business requirement to consider solutions that help bring down skyrocketing legal costs. Pharmaceuticals companies must be knowledgeable of, and abide by, specific information retention regulations in every country where they do business, including those countries that prohibit data from leaving the countries’ borders. Not having technology in place to help manage these requirements and increasing risks, or

Social Media Risks and Benefits for the Pharmaceuticals Industry
Drug makers are just beginning to realize how social networks can improve business processes. Social media helps your organization share information and exchange ideas with your customers quickly, but doing so can involve considerable risk. That’s because social media is subject to the scrutiny of regulators, legislators, and litigators. So, what seems like a spoon full of sugar is often a tough pill to swallow when you consider regulatory requirements from agencies like the FDA. On top of that, increasing litigation has made it a business requirement to consider solutions that help bring down skyrocketing legal costs. Not having technology in place to help manage these requirements and increasing risks, or doing so without careful planning, can be a costly mistake.
Read this paper to gain an understanding of:
What the regulatory landscape of the pharmaceuticals industry looks like
What concerns you should be aware of f

Ensuring the security of confidential, sensitive information is an essential element of enterprise Security and Governance, Risk Management and Compliance programs. Regulations, such as the HIPAA, FDA, and SOX, place significant requirements on organizations for securely sharing sensitive data such as confidential personally identifiable information (PII) and personal health information (PHI).

The pharmaceutical industry is very interested in using social media to promote products, services and issues important to it. However, many drug firm executives are uncertain about how to tackle the legal and regulatory issues associated with social media communications.

SMBs in regulated industries are also subject to the same data availability and data
protection requirements as large corporations for regulations such as HIPAA, FDA Part 11, Sarbanes-Oxley and SEC Rule 17, but without the budgets necessary to meet these requirements. This whitepaper provides six tips for an SMB approach to protecting data, such as confidential employee information, so download now to learn how keep your SMB protected from this critical loss of data.

Find out how a robust configuration audit and control system can enable electronic submissions and signatures, and validate electronic data, in compliance with the FDA's mandatory submission of clinical trials records.

The e-Learning industry has grown tremendously since the early days of computers and the Internet. Today there are lots of products and services out in the market place from which to choose. This white paper will provide some basic information to help you as you begin your research into e-Learning and learning management systems. The document is not meant to be the complete source of information on e-Learning nor will these guidelines be suitable for every single situation. This white paper has been created as a learning aid help you get started. These findings represent the research, experience, and techniques gleaned from working in e-Learning since its infancy in the late 80’s to today. At the end of the paper, Bob Goldschneider, Director of Business Development at SyberWorks, Inc., will provide a summary and closing remarks.

In most cases, the biggest quandary an organization must solve is to put together a rational, i.e., a cost justified, business case why they should spend capital to invest in a learning management system. The focus of this white paper will outline the benefits of web-based training along with a practical framework for developing ROI when looking at the cost of traditional training methods verses e-Learning.

This blind case study focuses on the operations division of a Fortune 500 company had significant challenges training its franchisees. They struggled with an 8 to 12 month backlog in providing training for their new franchisees coming on board. Anecdotally, when they did get around to training new people, the requirements and curriculum were outdated and in the process of being revised. Their franchisees and employees were never current on updated company policies and procedures. These franchises were spread all over the country, so it was costly to train their franchisees using traditional onsite training methods.

Jean Ann Larson, Chief Learning Officer (CLO), and Tawanna Foggs, Educational Systems Coordinator, of William Beaumont Hospitals, talk about their use of the SyberWorks Learning Management System to train and certify hospital employees.

Claudia Innes, Corporate Marketing Director for Fairchild Semiconductor, Inc. discusses their use of the SyberWorks Hosted e-Learning Solution to create a marketing-information portal to provide marketing and performance support for their sales staff, sales engineers, partners, and distributors in the power-supply segment.

Kevin Lange, Director of Field Training at Service Master Clean, Inc., talks about his company's training program and the organizational drivers that led them to consider an e-learning program and to choose the SyberWorks Training Center Learning Management System to manage their training.

The pharmaceutical industry is very interested in using social media to promote products, services and issues important to it. However, many drug firm executives are uncertain about how to tackle the legal and regulatory issues associated with social media communications.

In February 2004, the FDA issued a Draft Guidance requiring the electronic submission of labeling content to be provided in an XML-based format called Structured Product Labeling (SPL). The purpose of this white paper is for the reader to gain an understanding and prepare for the FDA's new electronic labeling submission standard.